Gender-related differences in venous thromboembolism patients: GARFIELD-VTE
ISTH Academy. G. Turpie A. 07/07/19; 263757; PB0562 Topic: VTE Risk Factors
Dr. Alexander G. Turpie
Dr. Alexander G. Turpie
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PB0562

Gender-related Differences in Venous Thromboembolism Patients: GARFIELD-VTE

P. Prandoni1, A.G.G. Turpie2, A.E. Farjat3, J.I. Weitz4, S. Haas5, W. Ageno6, S.Z. Goldhaber7, S. Goto8, P. Angchaisuksiri9, J. Dalsgaard Nielsen10, G. Kayani3, S. Schellong11, H. Bounameaux12, L. Mantovani13, A.K. Kakkar3, on behalf of the GARFIELD-VTE investigators
1Arianna Foundation on Anticoagulation Bologna, Selvazzano Dentro, Italy, 2Master University, Hamilton, Canada, 3Thrombosis Research Institute, London, United Kingdom, 4McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada, 5Formerly Technical University of Munich, Munich, Germany, 6University of Insubria, Department of Medicine and Surgery, Varese, Italy, 7Harvard Medical School, Boston, United States, 8Tokai University School of Medicine, Department of Medicine (Cardiology), Tokai, Japan, 9Ramathibodi Hospital, Mahidol University, Department of Medicine, Salaya, Thailand, 10Copenhagen University Hospital, Copenhagen, Denmark, 11Municipal Hospital Dresden, Medical Department 2, Dresden, Germany, 12University Hospital of Geneva and Faculty of Medicine, Geneva, Switzerland, 13University degli Studi di Milano Bicocca, Milan, Italy

Main Topic: Venous Thromboembolism
Category: VTE Risk Factors

Background: Venous thromboembolism (VTE) is a common cause of morbidity and mortality worldwide. There is a paucity of research investigating the influence of gender on characteristics, treatment patterns and outcomes in VTE patients.
Aims: Compare the baseline characteristics, treatment patterns, and 12-month clinical outcomes between males and females treated with anticoagulation therapy in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.
Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. 10,685 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017, 9,709 of which (male n=4897, female n=4812) received anticoagulation therapy and were eligible for analysis in this study.
Results: The distribution of VTE events was comparable (Male: 61.5% deep vein thrombosis (DVT) alone, 38.5% pulmonary embolism (PE) ± DVT; Female: 61.9% DVT alone, 38.1% PE ± DVT). Males and females were similar in both age; mean (standard deviation) 57.6 (15.7) years vs. 57.4 (18.0) years and BMI; mean (standard deviation) 27.9 (5.5) kg/m2 vs. 28.9 (7.5) kg/m2, respectively. Males were more likely to be a current/previous smoker (55.0% vs. 22.6%), but less likely to have been chronically immobilized (4.6% vs. 6.4%) or experienced a recent bleed/anaemia (2.1% vs. 4.5%). No clinically meaningful differences were found between anticoagulation treatment patterns at baseline between genders (Table 1). Over 12-months follow-up, event rates (95% confidence intervals) of all-cause mortality and recurrent VTE in males (vs females) were similar: 6.91 (6.18-7.72) vs 7.55 (6.77-8.40) and 5.02 (4.40-5.73) vs. 4.68 (4.08-5.38) per 100 person-years, respectively. Major and overall bleeding were significantly more frequent in females compared to males (1.32 (1.02 - 1.71) vs 1.91 (1.54 - 2.37) and 12.71 (11.66-13.85) vs. 8.67 (7.83-9.60), respectively (Table 2)).
Conclusions: Despite no differences in anticoagulation treatment at baseline, female VTE patients have an increased risk of bleeding compared to males over 12-months follow up.

Treatment Male (N=4987) Female (N=4812)
  N (%) N (%)
Parenteral therapy only 778 (15.9) 901 (18.7)
Parenteral therapy + VKA 1355 (27.7) 1268 (26.4)
VKA only 273 (5.6) 276 (5.7)
DOAC only 1578 (32.2) 1526 (31.7)
Parenteral therapy + DOAC 875 (17.9) 788 (16.4)
Other AC 38 (0.8) 53 (1.1)
[Table 1: Anticoagulation treatment at baseline (± 30 days of VTE diagnosis) in male vs female patients enrolled in GARFIELD-VTE.]



Event Male (n=4897) Female (n=4812) P value
  n Rate per 100 person-years (95% CI) n Rate per 100 person-years (95% CI)  
All-cause mortality 310 6.91 (6.18-7.72) 331 7.55 (6.77-8.40) 0.2661
Major bleed 59 1.32 (1.02-1.71) 83 1.91 (1.54-2.37) 0.0292
Recurrent VTE 219 5.02 (4.40-5.73) 200 4.68 (4.08-5.38) 0.4768
Any bleeding 370 8.67 (7.83-9.60) 516 12.71 (11.66-13.85) <0.0001
Stroke/Transient Ischemic Attack 35 0.78 (0.56-1.09) 30 0.69 (0.48-0.98) 0.5933
Myocardial Infarction/Acute Coronary Syndrome 35 0.78 (0.56-1.09) 26 0.59 (0.40-0.87) 0.2846
[Table 2: 12-month outcomes in male and female patients enrolled in GARFIELD-VTE.]

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